A study on treatment of COVID-19 patients with study drug along with standard of care
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2020/05/025369
- Lead Sponsor
- Medanta Institute of Education and Research MIER
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 180
I. Male or female subjects who are >=18 years of age, on the day of signing informed consent.
II. Patient or Legally Acceptable Representative (LAR) willing to give informed Consent before study procedure.
III. Hospitalized with COVID-19 infection confirmed per WHO criteria (including a positive PCR of any specimen; e.g., respiratory, blood, urine, stool, other bodily fluid).
IV. Moderate to severe COVID 19 infection (moderate disease â?? increased respiratory rate 15 to 30/minute and SpO2 90%-94%; and severe disease - respiratory rate >= 30/minute and/or SpO2 < 90% on room air, or ARDS or Septic shock
I. Known severe allergic reactions to TCZ or other monoclonal antibodies
II. Active tuberculosis (TB) infection.
III. Suspected or active bacterial, fungal, viral (except treated HCV or HBV infection), or other infection (besides COVID-19).
IV. In the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments.
V. Have received oral anti-rejection or immunomodulatory drugs (including TCZ) with in the past 6 months.
VI. Participating in other drug clinical trials
VII. Pregnant or breastfeeding, or positive pregnancy test in a pre-dose examination
VIII. Treatment with an investigational drug within 5 half-lives or 30 days (whichever is longer) of randomization
IX. Any serious medical condition or abnormality of clinical laboratory tests that, in the investigatorâ??s judgment, precludes the patient safe participation in and completion of the study.
X. Definite diagnosis of rheumatic immune related diseases.
XI. Administration of steroids equivalent to methylprednisolone at a dose >1mg/kg/day) at screening/baseline
XII. Absolute Neutrophil count <500, platelet count <50,000 per microliter at screening/baseline
XIII. Alanine aminotransferase (ALT) or aspartate aminotransferase(AST) >10 times upper limit of normal detected with-in 24 hours at screening/baseline
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method